Developing an OMERACT core outcome set for assessing safety components in rheumatology trials: The OMERACT safety working group

Louise Klokker, Peter Tugwell, Daniel E. Furst, Dan Devoe, Paula Williamson, Caroline B. Terwee, Maria E. Suarez-Almazor, Vibeke Strand, Thasia Woodworth, Amye L. Leong, Niti Goel, Maarten Boers, Peter M. Brooks, Lee S. Simon, Robin Christensen

Research output: Contribution to journalArticleAcademicpeer-review

11 Citations (Scopus)


Objective. Failure to report harmful outcomes in clinical research can introduce bias favoring a potentially harmful intervention. While core outcome sets (COS) are available for benefits in randomized controlled trials in many rheumatic conditions, less attention has been paid to safety in such COS. The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 emphasizes the importance of measuring harms. The Safety Working Group was reestablished at the OMERACT 2016 with the objective to develop a COS for assessing safety components in trials across rheumatologic conditions. Methods. The safety issue has previously been discussed at OMERACT, but without a consistent approach to ensure harms were included in COS. Our methods include (1) identifying harmful outcomes in trials of interventions studied in patients with rheumatic diseases by a systematic literature review, (2) identifying components of safety that should be measured in such trials by use of a patient-driven approach including qualitative data collection and statistical organization of data, and (3) developing a COS through consensus processes including everyone involved. Results. Members of OMERACT including patients, clinicians, researchers, methodologists, and industry representatives reached consensus on the need to continue the efforts on developing a COS for safety in rheumatology trials. There was a general agreement about the need to identify safety-related outcomes that are meaningful to patients, framed in terms that patients consider relevant so that they will be able to make informed decisions. Conclusion. The OMERACT Safety Working Group will advance the work previously done within OMERACT using a new patient-driven approach.

Original languageEnglish
Pages (from-to)1916-1919
Number of pages4
JournalJournal of rheumatology
Issue number12
Early online date15 Oct 2016
Publication statusPublished - 1 Dec 2017


  • Core outcome set
  • Harm
  • Omeract
  • Rheumatology
  • Safety

Cite this